Inflammatory bowel disease new choice! Ct-p13 subcutaneous preparation and intravenous preparation have the same efficacy and safety!

February 16, 2020 / BIOON / -- South Korean biopharmaceutical giant celltrion healthcare recently released a new one-year data of a randomized controlled trial The trial was carried out in patients with Crohn's disease (CD) and ulcerative colitis (UC), and the pharmacokinetic (PK), efficacy and safety of two dosage forms of biomimetic ct-p13 (infliximab) - intravenous (IV) and subcutaneous (SC) are being evaluated The results released at the 2020 European Crohn and colitis Organization (Ecco) annual conference in Vienna, Austria, showed that the efficacy and safety of the two preparations were comparable over a one-year treatment period The summary of this study has been selected as one of the highlights of Ecco In this study, 131 patients were randomly divided into two groups (66 in SC group and 65 in IV group) during the maintenance period 105 patients (80.2%) completed 54 weeks of follow-up (55 in SC group and 50 in IV group) After intravenous injection of 5mg / kg load dose (loading dose) at week 0 and 2, all patients were randomly assigned to group 2 at week 6: SC group received 120 mg (weight < 80kg) or 240 mg (weight ≥ 80kg) SC once every two weeks, IV group continued to receive 5mg / kg iv once every eight weeks From the 30th week, the IV 5mg / kg group turned to SC 120mg or 240mg (according to body weight) The results showed that: before the 30th week, the average CDAI (clinical disease activity index) and Mayo score of the two groups decreased with time; after the remaining IV patients turned to SC treatment, the clinical disease activity improved significantly at the 54th week The clinical response and remission rate remained unchanged at the 54th week, and the mucosal healing rate of CD and UC was further improved at the 54th week In addition, after conversion, the mean pre dose serum concentration of group IV increased to the same level as that of group SC, and remained the same level until the 54th week The overall safety profile of the SC and IV groups was comparable during the maintenance period and at or after week 30 Shomron Ben horin, M.D., Professor of gastroenterology at Chaim Sheba Medical Center in Israel, the lead investigator of the trial, said: "one year's results, including the conversion results, showed that ct-p13 SC and IV had considerable efficacy and safety These observations support the world's first infliximab SC preparation as a viable treatment agent to expand patient treatment options " Ct-p13 IV (remsim A / infectra, infliximab) was developed and manufactured by celltrion, and it is the first monoclonal antibody biosimilars approved by the European Commission (EC) It has therapeutic effect on 8 kinds of autoimmune diseases such as rheumatoid arthritis (RA) and infectious bursal disease The product was approved by the European Commission (EC) in September 2013 under the trade name of remsima and was launched in major European countries in early 2015 In the United States, ct-p13 was approved by FDA in April 2016 under the trade name of infractra By February 2020, ct-p13 has been approved in more than 94 countries, including the United States, Canada, Japan and Europe as a whole In terms of ct-p13 IV medication, the dosage in RA indication is 3mg / kg body weight, and the dosage in other indications is 5mg / kg, which is administered by intravenous drip for 2 hours All patients need to monitor any adverse reactions during infusion and at least 1-2 hours after infusion In addition to ct-p13 IV, celltrion has also developed ct-p13 SC preparation, i.e subcutaneous injection preparation The product can be administered in three ways: through pre filled pen (automatic syringe), pre filled syringe and pre filled syringe with needle protection SC preparations have the potential to enhance the therapeutic options of infliximab biosimilars through the use of high concentrations of drug exposure and convenient administration methods In Europe, preparation ct-p13 SC was approved in late November 2019 under the brand name remsima SC for the treatment of rheumatoid arthritis (RA) Celltrion has submitted a further application to the European Drug Administration (EMA) for preparation ct-p13 SC to expand the indications to other disease areas, including inflammatory bowel disease (IBD: Crohn's disease [CD] and ulcerative colitis [UC]), which is expected to be approved by mid-2020 In the United States, ct-p13 SC preparation will be reviewed through new drug route, and it is expected to obtain the approval of FDA in the United States by 2022 At present, celltrion has applied for patent protection to remsima SC in about 100 countries (including the United States, Europe and Asia) until 2038 Source of the original text: cellular healthcare cases positive 1-year results for new subcutaneous formula of infliximab in patients with active Crohn's disease and ultimate Sciences presented at the European Crohn's and Sciences Organization (Ecco) Annual Congress